Biopsy needle

ABSTRACT

A biopsy needle for collecting a tissue specimen includes an outer cannula that is at least partially received within a handle housing and an inner tube received within the outer cannula and configured to receive a stylet. A snare coil is attached between the inner tube and the outer cannula and a movable base is disposed within the handle housing. The outer cannula is fixedly coupled to the base and the movable base is axially movable within the handle housing. An inner driven structure that is coupled to the inner tube is configured to travel axially across an upper surface of the movable base. The coupling between the inner driven structure and the inner tube is such that the axial driving of the inner driven structure imparts rotation to the inner tube relative to the outer cannula.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 14/939,805, filed Nov. 12, 2015, which is based on and claimspriority to U.S. Patent Application Ser. No. 62/081,257, filed Nov. 18,2014 and U.S. Patent Application Ser. No. 62/170,934, filed Jun. 4,2015, each of which is hereby respectively incorporated by reference asif set forth in its respective entirety herein.

TECHNICAL FIELD

The present invention relates to a surgical instrument, typically knownas a biopsy device used to obtain tissue samples of a target specimenand more particularly, relates to a minimally invasive biopsy devicethat allows an operator to more precisely obtain substantially largertissue samples by manipulating the device's cutting mechanism forefficient engagement with a lesion or mass, resulting in improvedsampling of organs or other anatomical structures.

BACKGROUND

Patients are undergoing more minimally invasive procedures asalternatives to open surgical procedures. These less invasive proceduresuse a variety of devices which are placed in organs and tissues, orabdominal, pulmonary, urologic spaces with the goal of manipulating,cutting, capturing and/or stabilizing structures at a distance from theoperator. Retrieval of samples of tissues, masses, or lymph nodes may berequired for histopathologic diagnosis. In addition operative proceduresmay require the removal of tissue components to achieve the requisitesurgical result.

Standard or direct explorations or excisions of device components orretained materials, can be overly invasive and traumatic, andinconsistent with the basic principles of minimizing direct traumathrough minimally invasive procedures. Therefore, minimally invasivedevices and techniques have been developed to retrieve samples ofsuspicious lesions, masses or objects from the body. In additionstandard direct explorations to excise tissue specimens can also beoverly invasive and traumatic and are preferably completed withminimally invasive procedures.

There are a number of shortcomings in the designs of conventional biopsydevices and their application in clinical practice which limits theireffectiveness and/or simplicity. The success of the biopsy proceduredepends on the ability of the sampling device to efficiently andreliably obtain the foreign material. Similarly, the success of a biopsyprocedure depends on the ability of the biopsy device to efficiently andreliably capture a portion of tissue. The initial steps of a biopsyprocedure require that the sampling device must come in contact with theforeign material in a way that allows the device to engage it.

The object of the present invention is to provide a device thatovercomes these deficiencies and improves the biopsy procedure.

Other features and advantages of the present invention will be apparentfrom the following detailed description when read in conjunction withthe accompanying drawings.

SUMMARY

A biopsy needle for collecting a tissue specimen includes an outercannula that is at least partially received within a handle housing andan inner tube received within the outer cannula and configured toreceive a stylet. A snare coil is attached between the inner tube andthe outer cannula and a movable base is disposed within the handlehousing. The outer cannula is fixedly coupled to the base and themovable base is axially movable within the handle housing. An innerdriven structure that is coupled to the inner tube is configured totravel axially across an upper surface of the movable base. The couplingbetween the inner driven structure and the inner tube is such that theaxial driving of the inner driven structure imparts rotation to theinner tube relative to the outer cannula.

The needle includes a first biasing mechanism coupled to the movablebase for driving the movable base in a distal direction when the firstbiasing mechanism releases its stored energy and a second biasingmechanism is coupled to the inner driven structure for driving the innerdriven structure in a distal direction when the second biasing mechanismreleases its stored energy. The first biasing mechanism defines a firststage of operation and the second biasing mechanism defines a secondstage of operation. In the first stage, the release of the stored energyof the first biasing mechanism causes the movable base and the innertube and the outer cannula to travel axially in the distal direction andthe second biasing mechanism is configured such that after the movablebase travels a prescribed distance. The second biasing mechanismreleases its stored energy to cause rotation of the inner tube relativeto the outer cannula, thereby causing activation of the snare coil.

DETAILED DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 is a side perspective view of a biopsy device in an initialposition prior to actuation;

FIG. 1A is a cross-sectional view of an alternative mechanism forcoupling an inner tube and outer cannula of the device;

FIG. 2 is a side perspective view of the biopsy device after completionof a first stage of operation;

FIG. 3 is a side perspective view of the biopsy device after completionof a second stage of operation;

FIG. 4 is a side perspective view of a biopsy device according to asecond embodiment;

FIG. 5 is a side perspective view of a biopsy device according to athird embodiment;

FIG. 6 is side perspective view of a reset mechanism according to oneembodiment;

FIG. 7 is a side perspective view of a reset mechanism according toanother embodiment;

FIG. 8 is a side perspective view of a reset mechanism being shown in afirst position; and

FIG. 9 is a side perspective view of a reset mechanism according toanother embodiment in a first position.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

Now referring to FIGS. 1-3 in which a biopsy device 100 (specimenretrieving and capturing device or biopsy needle) of a snare coil designis illustrated and is configured to retrieve a target specimen which canbe in the form of a tissue specimen or a foreign material that islocated in certain organs or anatomical structures. To facilitate entryof the biopsy/capturing device 100 into organs or anatomical structuresor duct channels, the device 100 incorporates a catheter system.

Referring now to FIGS. 1-3, the retrieval device (biopsy needle) 100according to one exemplary embodiment is illustrated. The biopsy needle100 includes an inner tube 120 with a wire 200 at a distal end thereof,an outer cannula 130, a stylet 101 and a handle assembly 300. In oneaspect of the present invention, the handle assembly 300 includes abiasing (spring loaded) mechanism described in greater detail below thatpermits the user to selectively actuate the biopsy needle 100 so thatthe outer cannula 130 and the inner tube 120 are rapidly advanced beyondthe stylet 101 to provide a shearing action of the soft tissue specimen.

The present biopsy needle 100 is particularly constructed for softtissue biopsy applications since the spring loaded mechanism provides animproved means of removing the tissue after it is cored as well asproviding an improvement in the way that the tissue is acquired by thebiopsy needle 100. The handle assembly 300 includes a handle body 310that can be formed in a number of different shapes and sizes and isgenerally a hollow body that contains the spring loaded mechanism. Forpurpose of illustration only, the handle body 310 of FIG. 1 is agenerally rectangular or cylindrical or square body; however, handlebody 310 preferably is an ergonomically pleasing shape that allows forsecure grasping and accurate positioning of the needle tip by theoperator.

The inner tube 120 includes a distal end 121 and an opposing proximalend 122. The inner tube 120 can have any number of differentcross-sectional shapes; however, in one embodiment, the inner tube 120has a circular cross-section. The inner tube 120 can include an annularshaped groove 124 that is spaced from the proximal end 122.

The outer cannula 130 can be similar or identical to the outer tubedisclosed in one of the aforementioned patents. More specifically, theouter cannula 130 can include a distal end 131 and an opposing proximalend 132. The outer cannula 130 can also have any number of differentcross-sectional shapes with one embodiment being a circular tubestructure. At or near the proximal end of the outer cannula 130, theouter cannula 130 can include a protrusion 135, such as a bump, thatmates with and is received within the annular groove 124. A snap-fit canbe formed between the outer cannula 130 and the inner tube 120. Thereception of the protrusion 135 into the annular groove 124 couples thetwo members together such that the two members move longitudinally inunison, while the inner tube 120 can rotate relative to the outercannula 130 (i.e., the bump travels within the annular groove).

In accordance with the present invention, the inner tube 120 and theouter cannula 130 are coupled to one another such that the inner tube120 and the outer cannula 130 move together, in unison, in an axialdirection, while the inner tube 120 is permitted to rotate relative tothe outer cannula 130 for activating and deactivating the snare. Anynumber of different mechanisms can be used to achieve the foregoingcoupling between the outer cannula 130 and the inner tube 120.

Alternatively and as shown in FIG. 1A, the inner tube 120 can include aflange 180 that is spaced from the proximal end 122 and extendsoutwardly from the inner tube 120. The flange 180 can be in the form ofan annular flange that extends completely around the inner tube 120 orit can be in the form of one or more protrusions, e.g., tabs, thatextend outward from the inner tube 120. The flange 180 can be in theform of an annular ring.

Alternatively, at the proximal end 132 of the outer cannula 130, aflange 182 is formed. As with the flange 180 formed as part of the innertube 120, the flange 182 of the outer cannula 130 can be in the form ofan annular flange or it can be formed by one or more protrusions ortabs.

The inner tube flange 180 and the outer tube flange 182 can bepositioned adjacent to each other along the longitudinal axis of theinner tube/outer tube assembly to limit displacement of the tubesrelative to each other when they are both projected forward orrepositioned back into the handle assembly. Alternatively, the innertube flange 180 may be positioned adjacent to the proximal end of theouter tube 130 to limit displacement of the inner and outer tubes 120,130 relative to each other during forward projection of the inner/outertube or repositioning of the inner/outer tube into the handle assembly.In this side by side flange configuration, the inner and outer tubes120, 130 remain aligned and move uniformly without displacing the onetube relative to the other tube, partly as a result of the lip andgroove engagement mechanism represented by the annular groove 124 andthe protrusion 135.

In one embodiment, shown in FIG. 1A, in which the inner tube 120 andouter cannula 130 include flanges 180, 182, respectively, the flange 180of the inner tube 120 includes a first locking lip 184 that creates aspace 185 between the lip 184 and the flange 180. The first locking lip184 has a first portion 186 and a second portion 187 that is parallel tothe flange 180, with the first portion 186 being perpendicular to theflange 180 and connects the second portion 187 to the flange 180.

The outer cannula 130 includes a complementary second locking lip 190that is received within space 185 between the first locking lip 184 andthe flange 180, thereby coupling the parts 120, 130 to one another. Thesecond locking lip 190 has a first portion 192 and a second portion 194that is parallel to the flange 182, with the first portion 192 beingperpendicular to the flange 182 and connects the second portion 194 tothe flange 182. The second portion 194 is parallel to flange 182. Thesecond portion 194 is thus received within the space 185, therebycoupling the two 120, 130 together in a longitudinal direction, whilepermitting the two 120, 130 to rotate relative to one another. In thismanner, the lip portions interlock with one another and preventindependent axial movement between the inner tube 120 and the outercannula 130, while still permitting rotation of the inner tube 120relative to the outer cannula 130.

In the case of the protrusion 135 and annular groove 124 embodiment, asillustrated, the protrusion 135 is received in the groove 124 andreleasably retained therein.

The handle body 310 includes an opening 311 formed at a distal endthereof through which the combined inner tube 120/outer cannula 130pass. The opening 311 allows the combined inner tube 120/outer cannula130 to move in the axial direction between the retracted position andthe extended position in which more of the combined inner tube 120/outercannula 130 is exposed distally beyond and outside of the handle body310. This opening 311 allows the combined inner tube/outer cannula to befired and retracted as described herein.

Both the inner tube 120 and the outer cannula 130 are axially movablethrough the displacement of a movable base 400 that is disposed withinthe handle body 310. The movable base 400 can be thought of as being asled that is controllably moved a defined distance within the hollowinterior of the housing 300. The base 400 has a first end 402, anopposing second end 404, a top surface 406 and an opposing bottomsurface 408. In accordance with the present invention, the combinedinner tube 120/outer cannula 130 are coupled to the base 400 such thatthe axial movement of the base 400 (in either direction) is translatedinto axial movement of the combined inner tube 120/outer cannula 130.More specifically, the outer cannula 130 can be coupled to the topsurface 406 of the base 400 using any suitable technique. For example, amechanical coupling (fit) can be formed or an adhesive or chemicalbonding can be used.

In one embodiment, the combined inner tube 120/outer cannula 130 isfixedly attached to the base 400 such that the base 400 acts as acarrier for the combined inner tube 120/outer cannula 130.

In one embodiment, the top surface 406 has a contoured surface in whichthe top surface 406 includes a recessed section and more specifically,the recessed section in the top surface 406 comprises a concave section407 defined by a concave surface. The concave surface 407 does not haveto extend the entire length of the top surface 406 but instead can onlyextend a length thereof less than the entire length. When the concavesurface 407 does not extend to either of the ends of the base 400, theconcave surface 407 can be defined by a first end edge and/or a secondend edge. As described below, one or more of these end edges can act asa stop. Alternatively, the top surface recessed section may beconfigured in other non-concave morphologic conformations.

There are any number of different ways to construct the base 400 suchthat it is axially movable within the handle body 310. In particular,the base 400 can ride along one or more guides 450 that permit axialmovement both in a distal direction and a proximal direction. Forexample, a pair of guides 450 can be provided with each of the guides450 being in the form of an elongated rod. The two rods 450 are fixedlyanchored at their ends to the ends of the handle body 310. The two rods450 are thus spaced apart from one another and are parallel to oneanother. The base 400 has a pair of bores formed along a length thereofand configured to receive the rods 450. The base 400 thus freely ridesalong the rods 450 in both a distal axial direction and a proximal axialdirection. The rods 450 also support and suspend the base 400 within thehollow interior of the handle body 310.

Alternatively, the base 400 can have one or more tabs or fingers thatdepress downwardly therefrom and are received within a complementaryreceived track formed in the handle body 310. The recessed track is alongitudinal track that allows the base 400 to move in an axialdirection within the handle body 310. The ends of the track define theends of travel of the base 400.

The base 400 can have any number of different shapes including arectangular or square shape as shown.

As shown, one end (e.g., the proximal end) of the base 400 includes afirst support member or wall 410. The wall 410 is a vertical wall thatextends upwardly from the base 400. The wall 410 can extend across theentire width of the base 400 as shown. The wall 410 can also include anopening 413 (FIG. 2), such as a circular opening as shown. The opening413 can be configured to allow the stylet to pass therethrough.

Within the interior of the handle body 310, a second support member orwall 420 can be provided. The second support member 420 can be attachedto the proximal end of the stylet so as to permit the stylet to moverelative to the combined inner tube/outer cannula, to facilitateextending the stylet further into the targeted tissue prior to releasingthe combined inner tube/outer cannula into the tissue. However, inpractice when activated, the needle projects the combined innertube/outer cannula over the steadfast stylet. As understood, the styletis used to initially locate and target the tissue to be biopsied in thatthe distal end of the stylet is placed into intimate contact with thetarget tissue.

The second support wall 420 is preferably parallel to the first wall410. The second support wall 420 is oriented proximal to the first wall410. The second support wall 420 can engage a lock mechanism thatensures that the second support wall 420 remains in a locked position.For example, a latch mechanism or the like can be used to lock thesecond support wall 420 in place. The handle body 310 can be constructedsuch that the second support wall 420 can be removed from the handlebody 310 as by being removed through an opening formed in the handlebody 310. Once the combined inner tube 120/outer cannula 130 projectforward as described herein, the stylet can be removed to then allowremoval of the captured tissue. Alternatively, the stylet remains inplace and functions as a extracting dowel member which forces the tissuespecimen from the internal aspect of the inner tube as the combinedinner tube/outer cannula assembly is displaced back into the handleassembly for reactivation.

Before proceeding to an explanation of the other operable components ofthe spring loaded mechanism, it is helpful to understand that generallythe inner tube 120 and outer cannula 130 are positionable between twopositions, namely, a fully retracted position and a fully extendedposition. In the fully retracted position, the inner tube 120 and outercannula 130 are reset back into the handle body 310 and a biasingelement(s) of the spring loaded mechanism stores energy. In contrast,after the user activates the spring loaded mechanism, the biasingelement releases its energy and an axial force is applied to the innerand outer tube structure in a direction away from the handle body 310,forcing the inner and outer tube structure into the tissue to besampled.

In both the fully retracted and fully extended positions, the protrusion135 is mated to the groove 124 coupled to one another, as describedbelow, so that a force applied to one of the inner tube 120 and theouter cannula 130 is translated to the other of the inner tube 120 andouter cannula 130.

In order to generate a force that is sufficient to shear the softtissue, the spring loaded mechanism includes a first biasing element320, such as a coil spring, that applies a force against a face of thefirst wall 410. The size and/or location of the first biasing element320 is selected such that the first biasing element 320 has a greaterdiameter than the opening 311, therefore lying outside the opening.

The first biasing element 320 is disposed between the first wall 410 andthe second wall 420. The second wall 420 can be fixed in place such thatthe first biasing element 320 can be compressed between the two walls410, 420 by moving the base 400 in a direction towards the second wall420 since the base 400 is axially movable. The first biasing element 320thus represents the means for axially projecting the combined inner tube120/outer cannula 130.

The first biasing element 320 can be in the form of a spring (e.g., coilspring) that can store energy as well as other energy storingelement(s). When the first biasing element 320 releases its energy, thespring exerts a force against the second support wall 420 to cause theaxial movement of the entire base 400 in a distal direction since thesecond support wall 420 is attached to the base 400.

The device 100 also includes a means for causing the selective rotationof the inner tube 120 relative to the outer cannula 130. In particular,the means is in the form of a curvilinear tube 150 (which can be thoughtof as an inner driven structure). The curvilinear tube 150 has a firstend 152 and an opposing second end 154. The curvilinear tube 150 issized and configured to seat along the upper surface 406 of the base 400and more particularly, the curvilinear tube 150 is disposed within theconcave surface 407 of the upper surface 406 of the base 400. Asdescribed herein, the curvilinear tube 150 is axially movable within theconcave surface 407 of the base 400. While the inner surface of thecurvilinear tube is generally cylindrical, the outer surface need not becylindrical and can take one of many shapes, even cubelike in nature, aslong as the tube can be displaced axially along the surface 406 within acomplementary shaped indentation.

The curvilinear tube 150 is coupled to the inner tube 120 such that thecontrolled axial displacement of the curvilinear tube 150 is translatedinto the controlled rotation of the inner tube 120, thereby providingthe means for closing and opening the snare. The ends 152, 154 of thecurvilinear tube 150 are open to allow passage of the stylet through thetube 150. In addition, the central opening of the curvilinear tube 150allows for reception of the inner tube 120. The inner tube 120 can passthrough the open first end 152 but not pass through the open second end154 (in other words, the proximal end of the inner tube 120 is locatedinternally within the interior of the tube 150).

The curvilinear tube 150 has an outer surface 151 and an inner surface.In one embodiment, a pin and groove mechanism is used to couple theinner tube 120 to the curvilinear tube 150. For example, the curvilineartube 150 can include at least one groove 153 formed in the innersurface, with the groove 153 having a helical shape. It will beunderstood that the groove 153 can be in the form of a helical slotformed through the tube. The inner tube 120 includes at least onecomplementary pin 155 that is configured to be received within thegroove 153. In one embodiment, the inner tube 120 can have a single pin155 or the inner tube 120 can have a pair of pins 155 that are disposedopposite one another (180 degrees apart). When the inner tube 120 has apair of pins 155, the curvilinear tube 150 has a pair of complementaryslots/grooves 153 that are symmetrically opposite one another.

Each pin 155 extends radially outward from an outer surface of the innertube 120. The pin 155 does not extend internally within the interior ofthe inner tube 120. In the case of having two pins 155, the pins 155 areaxially aligned and extend radially outward from the outer surface ofthe inner tube 120 at two opposite points thereof.

Each pin 155 is received into the respective groove/slot 153 and thelinear (axial) movement of the curvilinear tube 150 is translated intothe pin 155 riding along the groove 153. Since the groove 153 has ahelical shape, the pin 155 riding within the groove 153 causes rotationof the inner tube 120 since the curvilinear tube 150 is prevented fromrotating within the handle body 310.

In yet another embodiment, the pin 155 can be associated with thecurvilinear tube 150 (i.e., can protrude inwardly from the inner surfacethereof) and the helical shaped groove 153 can be formed along the outersurface of the inner tube 120. As in the other embodiments, the pin 155is received within the groove 153 and the firing of the curvilinear tube150 causes the pin 155 to ride within and along the length of the groove153. As in the previous embodiment, there can be more than one pin 155and more than one corresponding groove 153 to create the desiredrotation of the inner tube 120.

Any number of different mechanisms can be employed that permit thecurvilinear tube 150 to move axially along the upper surface 406 of thebase 400; however, the curvilinear tube 150 is prevented from rotating.Since the curvilinear tube 150 can only move in a linear direction, theinner tube 120 is the member that has rotation imparted thereto. In oneembodiment, the outer surface of the curvilinear tube 150 can have aprotrusion 159 extending radially outward therefrom, with the protrusionbeing received within a linear guide track or slot 313 formed in thehandle body 310 (e.g., formed along a side wall of the body 310) or inthe upper surface 406 of 400 or in the complimentary recess 407. Thereception of the protrusion 159 within the linear track restricts thedegree of motion of the tube 150 and in particular, forces thecurvilinear tube 150 to only move in a linear direction along the uppersurface 406 within the concave portion 407 and across the upper surface406. In another embodiment, the protrusion 159 extending outward fromthe curvilinear tube 150 can be received within a linear guide slotformed in the base 400 and more particularly, formed within the concaveportion 407 of the base 400. Both of these arrangements constrain thetype of movement of the curvilinear tube 150 that is permissible and inparticular, only allows the curvilinear tube 150 to be fired forward(linearly) and similarly retracted backwards (linearly) without itrotating around the longitudinal axis.

The device 100 also includes a second biasing mechanism 455 which servesto controllably fire the curvilinear tube 150 as part of a second stageof operation of the device. As described in detail herein, the secondstage is operable after the first stage concludes. The first stage beingagain the forward advancement of the base 400 and the combined innertube/outer cannula so as to drive the combined inner tube/outer cannulainto the target tissue. The second biasing mechanism 455 is disposedbetween the proximal end of the curvilinear tube 150 and a distal faceof the first wall 410. The second biasing mechanism 455 can be in theform of a spring or other elements that can reversibly store energy.Energy is stored when the spring 455 is compressed by reducing thedistance between the proximal end of the curvilinear tube 150 and thefirst wall 410. As with the first biasing mechanism, the second biasingmechanism is positioned such that its diameter or outer aspect liesoutside of the opening formed in the first wall 410 (to allow passage ofthe stylet).

In the initial position (loaded position) of the curvilinear tube 150,the spring 455 is compressed and stores energy. In the initial position,the curvilinear tube 150 is disposed proximally in the concave section407 of the base 400. Under select conditions, when the second spring 455releases its energy, the curvilinear tube 450 is propelled forward in alinear manner within the concave surface 407. The curvilinear tube 450travels a prescribed distance that is sufficient to cause the pin(s) 155to travel within the helical groove(s) 153 resulting in rotation beingimparted to the inner tube 120 since the curvilinear tube 150 can onlymove linearly and axially. The pin 155 can travel the length of thegroove or can travel a substantial length of the groove so long as thedistance traveled is sufficient to cause the inner tube 120 to rotatesufficiently to cause activation of the snare.

The device 100 also includes a means for controllably firing both thebase 400 and the curvilinear tube 150. More specifically, a firstrelease (lock) member 500 is provided and is accessible to the user tocause the base 400 to be fired forward as a result of the release of thestored energy of the first biasing mechanism 320. The first releasemember 500 can take any number of different forms so long as it has aportion that is accessible to the user and has a portion thatselectively engages the base 400. For example, the first release member500 can be in physical engagement with the base 400 such that when thefirst release member 500 disengages the base 400, the stored energy ofthe first spring 320 is released. This results in the forward firing ofthe base 400 and also the combined inner tube/outer cannula. The firstrelease member 500 can be in the form of a physical structure that locksthe base 400 in the initial retracted position and when the physicalstructure is moved such that contact with the base 400 is eliminated,the base 400 is free to move linearly and the first spring 320 providesthe energy to drive the base 400. In the illustrated embodiment, thefirst release member 500 is in the form of a movable catch 502 (claw)that engages a portion of the base 400. For example, the first releasemember 500 includes a first section 504 that lies outside of the handlebody 310 and is accessible by the user. This first section 504 can be inthe form of a button, a slider, etc. The first release member 500 has asecond section 506 that is connected to the first section 504 (or isintegral therewith) and represents the portion of the release member 500that selectively engages the base 400. The second section 506 ismovable, such as being pivotable, so as to allow the second section 506and the 502 claw engaging section to be moved out of contact with thebase 400 when the user manipulates the first section 504. The firstrelease member 500 can be biased (as by a spring) such that it normallyassumes one position. As described herein, a cam can be provided tofacilitate the relocking of the base 400 after the two stages ofoperation are complete.

A second release (lock) member 510 is in the form of a physicalstructure that locks the curvilinear tube 150 in place along the base400 in the initial retracted position and when the physical structure ismoved such that contact with the curvilinear tube 150 is eliminated, thecurvilinear tube 150 is free to move linearly and the second spring 450provides the energy to drive the curvilinear tube 150 along the uppersurface 406 of the base 400. In the illustrated embodiment, the secondrelease member 510 is in the form of a movable catch 512 (claw or prong)that engages a portion of the curvilinear tube 150 (e.g., a front edgeof the curvilinear tube).

Unlike the first release member 500, the second release member 510 iscompletely disposed internally within the handle body 310 and is notaccessible by the user. As a result, the disengagement of the secondrelease member 510 occurs automatically without user intervention whenthe base 400 reaches a certain location within the handle body 310. Thesecond release member 510 is thus coupled to the base 400, and may be anintegral part of the base 400. The second release member 510 isnaturally biased in an upward position such that when the properregistration exists between the second release member 510 and thecurvilinear tube 150, the second release member 510 actively engages thecurvilinear tube 150 and prevents linear (longitudinal) movementthereof.

The catch 512 extends upward, possibly through an opening or slot formedin the base 400 to engage the distal end of the curvilinear tube 150.Alternatively, the curvilinear tube 150 can have a recess in which thecatch 512 is received when the curvilinear tube 150 is in the retractedposition and registration exists between tube 150 and the second releasemember 510. In the initial position of the base 400, the curvilineartube 150 is also in the initial retracted position and the catch 512 isin engagement (intimate contact) with the distal end of the curvilineartube 150. As the base 400 is projected (driven) forward by the releaseof the energy of the first spring 320, the catch 512 engages a camsurface that is located at a fixed location. When the catch 512 engagesthe cam surface, the catch 512 disengages from being in contact with thedistal end of the curvilinear tube 150 (or disengages from a slot orrecess formed in the tube 150), thereby releasing the curvilinear tube150 and allowing the firing thereof (due to release of the stored energyof the second spring).

The base 400 is thus constructed to allow for the inclusion andoperation of the second release member 510 in that during the firing ofthe base 400 in the first stage, the second release member 510 does notinterfere with such movement of the base 400. Only when the base 400 hastraveled a prescribed distance does the second release member 510disengage from the curvilinear tube 150 resulting in the beginning ofthe second stage of operation.

Thus and in accordance with the present invention, the second releasemember 510 is not disengaged from the curvilinear tube 150 until thefirst stage reaches its completion or reaches its substantialcompletion. In other words, the curvilinear tube 150 is not advancedaxially (fired forward) until the base 400 reaches its end of travel orreaches its substantial end of travel. This results in the second stagebeing activated after the first stage has been activated and has reachedcompletion and consequently, the snare is only activated after the innertube/outer cannula has been advanced into contact with the targettissue, and substantially penetrated the tissue.

The device 100 also preferably incorporates one or more stops forlimiting the degree of travel of the base 400 and/or the curvilineartube 150. For example, a first stop can be provided for stopping thebase 400 and thus, terminate the forward progression (forward firing) ofthe base 400. The stop can be a tab or other protrusion that is locatedalong the travel of the base 400. The stop can be located prior to thedistal end of the handle body 310 so as to prevent the distal end of thebase 400 from contacting the distal end (wall) of the handle body 310. Asecond stop is configured to limit the degree of travel of thecurvilinear tube 150 along the upper surface 406 of the base 400. Thesecond stop can take any number of different constructions including theconcave section 407, which can terminate in a hard distal end edge thatcan act as a stop in that when the curvilinear tube 150 contacts thisend edge, the axial travel of the curvilinear tube 150 ends. The secondstop can alternatively be in the form of a protrusion that is locatedwithin the concave section 407. This protrusion serves to contact theend edge of the curvilinear tube 150 and prevent further axial movementin the distal direction. Yet another stop can be the end of the groove153 formed in the curvilinear tube 150 in that when the pin 155 reachesthe proximal end of the groove 153, the curvilinear tube 150 has reachedits end of distal travel.

Each of these stops is designed to stop the respective movement of oneof the base 400 and the curvilinear tube 150.

The device 100 can have one or more reset mechanisms that are used afterthe device 100 has competed both the first stage (firing of the innertube/outer cannula into the target tissue) and the second stage(rotation of the inner tube relative to the outer cannula to causeactivation of the snare). These may serve as stops for the base 400 andcurvilinear tube 150, as well. In the embodiment shown in FIGS. 1-3,there are two separate reset mechanisms, namely, a first reset mechanism600 for resetting the curvilinear tube 150 to its initial position and asecond reset mechanism 610 for resetting the base 400 to its initialposition.

The first reset mechanism 600 is configured to physically move thecurvilinear tube 150 in the proximal direction and across the topsurface 406 to the initial position. The first reset mechanism 600 canthus be a physical structure that contacts and applies a force againstthe curvilinear tube 150 (e.g., against the distal end thereof) anddrive the curvilinear tube 150 to the initial position. However, thefirst reset mechanism 600 does not limit the distal projection of thebase 400 or the curvilinear tube 150 and therefore does not interferewith the operation of both the base 400 and the curvilinear tube 150(i.e., the forward firing of the base and combined inner tube/outercannula).

The illustrated first reset mechanism 600 can be in the form of a slider602 that travels within a guide slot 604 (linear slot) formed in thehandle body 310. The slider 602 has a first section 606 that can beaccessed by the user to allow the user to drive the slider 602 withinthe guide slot 604 and a second section 608 that extends downward fromthe first section 606. The second section 608 is the section thatcontacts and drives the distal end of the curvilinear tube 150 in theproximal direction to its reset position. The slider 602 can thus havean L shape as well as a variety of other configurations.

In one embodiment, the guide slot 604 has a length such that when theslider 602 is at a distal end thereof, the slider 602 is beyond thedistalmost point of travel of the curvilinear tube 150. As a result, theslider 602 does not impede the travel (firing) of the curvilinear tube150.

The slider 602 works by physically driving the curvilinear tube 150 in aproximal direction until the second release member 510 reengages withthe curvilinear tube 150. The user can receive auditory feedback (aclick noise) and/or tactile feedback (feel a clicking engagement) toindicate that the curvilinear tube 150 has been successfully reset. Oncethis confirmation (feedback) is received by the user, the user can thenmove the slider 602 in the distal direction toward a rest positionthereof (which does not obstruct the subsequent firing of thecurvilinear tube 150).

Similarly, the second reset mechanism 610 is configured to physicallymove the base 400 in the proximal direction. The second reset mechanism610 can thus be a physical structure that contacts and applies a forceagainst the base 400 (e.g., against the distal end thereof) and drivethe base 400 to the initial position. However, the second resetmechanism 610 does not interfere with the operation of both the base 400and the curvilinear tube 150 (i.e., the forward firing of the base andcombined inner tube/outer cannula).

The illustrated second reset mechanism 610 can be in the form of aslider 612 that travels within a guide slot 614 (linear slot) formed inthe handle body 310. The slider 612 has a first section 616 that can beaccessed by the user to allow the user to drive the slider 612 withinthe guide slot 614 and a second section 618 that extends downward fromthe first section 616. The second section 618 is the section thatcontacts and drives the distal end of the base 400 in the proximaldirection to its reset position. The slider 612 can thus have an L shapeas well as other configurations. The locations of the two resetmechanisms 600, 610 are mutually coexistive in that the two sliders areradially offset from one another.

In one embodiment, the guide slot 614 has a length such that when theslider 612 is at a distal end thereof, the slider 612 is beyond thedistalmost point of travel of the base 400. As a result, the slider 612does not impede the travel (firing) of the base 400.

The slider 612 works by physically driving the base 400 in a proximaldirection until the first release member 500 reengages with the base400. The user can receive auditory feedback (a click noise) and/ortactile feedback (feel a clicking engagement) to indicate that the base400 has been successfully reset. Once this confirmation (feedback) isreceived by the user, the user can then move the slider 612 in thedistal direction toward a rest position thereof (which does not obstructthe subsequent firing of the base 400).

The operation of the device 100 is as follows. The device 100 isinitially in a rest (retracted) position shown in FIG. 1. The usergrasps the device 100 by the handle body 310 and then the user advancesand/or places the stylet at the target tissue. The user then actuatesthe device by pressing, sliding or otherwise manipulating the firstrelease member 500 thereby unlocking the base 400 and initiating thefirst stage of operation. The first spring 320 releases its energy andpropels the base 400 in the distal direction thereby causing thecombined inner tube 120/outer cannula 130 to be driven (fired) into thetarget tissue. This movement is shown in FIG. 2.

As described herein, the second stage automatically follows the firststage and the forward projection of the curvilinear tube 150 along thetop surface 406 causes the rotation of the inner tube 120 relative tothe outer cannula 130, thereby causing the winding up (activation) ofthe snare. This results in the tissue specimen at the target site beingcaptured. The device 100 can then be removed from the patient's body andthen the first and second reset mechanisms can be actuated to cause theresetting of the curvilinear tube 150 which results in the snare openingto allow the user to retrieve the captured specimen. FIG. 3 shows thedevice 100 after completion of the first and second stages.

FIG. 4 shows a device 700 that is similar to the device 100 with theexception that the device 700 includes two first springs 320. The twosprings 320 are disposed side-by-side with the two springs 320 beingdisposed outside (lateral) to the opening 413 formed in the wall 410.The use of two springs 320 provides increased biasing force to drive theinner tube/outer cannula into the target tissue. FIG. 5 shows a device705 with an additional first spring 320 and therefore, there are threetotal first springs to create the biasing force and propel the base 400in the distal direction. The center spring 320 can be disposed aroundthe opening 413 in the wall 410. As can be appreciated any number ofmultiple springs can be positioned between the 410 and 420 walls.

FIG. 6 shows a different reset mechanism 710 and in particular, thereset mechanism 710 includes a double pronged single slider 715. Theslider 715 slidably travels within a pair of linear guide slots 720formed in base 400. The slider 715 includes a first section 717 that isaccessible to the user along the outside of the handle body 310. Thefirst section 717 can be a ribbed pusher which is contacted by theuser's thumb. The slider 715 has first and second prongs 718, 719 thatdepend downwardly from the first section 717. However 718 and 719 couldalso represent the two sides of a curvilinear double pronged member, orother similar configurations. The base 40 includes a pair of guide slots720 for receiving the two respective prongs 718, 719. The two slots 720are open at the distal end of the base 400 and open into the concavesurface at 722 and terminate at proximal ends 724. The slots 720 canpass all the way through the base 400 or can be recessed in the base 400but not pass all the way therethrough. The slots 720 can terminate atends 724 that are within the concave surface 407 allowing the prongs tobe displaced proximally into the concave recess.

The slider 715 operates by being directed into the open ends of theslots 720 and as the slider 715 is directed in the proximal direction,the two prongs 718, 719 contact the distal end of the curvilinear tube150 and continued driving of the slider 715 causes the curvilinear tube150 to rest to the initial position. Once the curvilinear tube 150 isdisplaced proximally, continued driving of the slider 715 results in theprongs 718, 719 contacting the closed ends 724 and thus, continueddriving of the slider 715 causes the entire base 400 to move in theproximal direction. Once the base 400 resets to the initial position,the slider 715 can then be moved in the distal direction.

FIGS. 7 and 8 show another variation of the slider 715 in that theprongs 718, 719 are disposed above the upper surface 406 of the base 400but are spaced and positioned such that the prongs 718, 719 contact thedistal end of the curvilinear tube 150. The driving of the slider 715 inthe proximal direction results in the prongs 718, 719 passing over theupper surface 406 and then into contact with the curvilinear tube 150.Continued driving of the slider 715 causes movement of the curvilineartube 150 in the proximal direction until it is reset. The proximal endof the concave section 407 can include a stop (such as a tab or lip) andtherefore, when the curvilinear tube 150 is driven into contact withthis stop, the continued driving of the slider 715 in the proximaldirection causes the resetting of the base 400 since the stop is part ofthe base 400 and driving of the tube 150 against the stop causes adriving of the base 400 in the proximal direction.

FIG. 8 shows the slider 715 in a first position spaced from the base 400and curvilinear tube 150 and FIG. 7 shows a second position, in whichthe slider 715 is in contact with the curvilinear tube 150. As shown inFIGS. 7 and 8, the length of the concave section 407 can be customized.

FIG. 9 shows a different reset mechanism 800 in the form of a singlepronged single slider. The configuration is similar to the mechanismshown in FIG. 1 except for the fact that instead of including twosliders to sequentially reposition the curvilinear tube 150 and then thebase 400, one slider 805 is used. The slider 805 has one projectingelement or prong 810. Unlike the previous embodiment, the prong 810 doesnot move within a track within the base 400 since it is positionedsuperior to the outer cannula 130. The prong 810 first engages thesuperior portion of the curvilinear tube 150. After repositioning thecurvilinear tube 150 which then is locked into place by there-engagement of the releasing lever (which is positioned inferior tothe tube), continuing to apply force to the curvilinear tube 150transmits the translational force to the base 400 which is then rebiasedinto its fireable position.

In order that a substantial force is not applied to the releasing leverduring the re-biasing of the base 400, the curvilinear tube 150 can cometo rest against a type of ledge in the base 400 which keeps it fromtranslating beyond a certain position on the sled 400 when it is in itsrebiased position.

What is claimed is:
 1. A biopsy needle for collecting a tissue specimencomprising: a handle housing; an outer cannula that is at leastpartially received within the handle housing; an inner tube receivedwithin the outer cannula and configured to receive a stylet, wherein theouter cannula and inner tube extend distally beyond a distal end of thehandle housing; a snare coil attached between the inner tube and theouter cannula; a movable base disposed within the handle housing,wherein the outer cannula is fixedly coupled to the base, the movablebase being axially movable within the handle housing; an inner drivenstructure that is coupled to the inner tube and is configured to travelaxially across an upper surface of the movable base, wherein thecoupling between the inner driven structure and the inner tube is suchthat the axial driving of the inner driven structure imparts rotation tothe inner tube relative to the outer cannula; a first biasing mechanismcoupled to the movable base for driving the movable base in a distaldirection when the first biasing mechanism releases its stored energy; asecond biasing mechanism coupled to the inner driven structure fordriving the inner driven structure in a distal direction when the secondbiasing mechanism releases its stored energy; wherein the first biasingmechanism defines a first stage of operation and the second biasingmechanism defines a second stage of operation, wherein in the firststage, the release of the stored energy of the first biasing mechanismcauses the movable base and the inner tube and the outer cannula totravel axially in the distal direction and the second biasing mechanismis configured such that after the movable base travels a prescribeddistance, the second biasing mechanism releases its stored energy tocause rotation of the inner tube relative to the outer cannula, therebycausing activation of the snare coil.
 2. The needle of claim 1, whereinthe outer cannula is fixedly attached to the upper surface of the base.3. The needle of claim 1, wherein a proximal end of the inner tube isdisposed within an interior of the inner driven structure.
 4. The needleof claim 1, wherein the snare coil comprises a distal section of theinner tube with a distal end of the snare coil being attached to theouter cannula.
 5. The needle of claim 1, wherein the inner drivenstructure comprises a curvilinear tube that has at least one helicalshaped groove formed therein, the inner tube having at least oneprotrusion extending outwardly from an outer surface thereof and beingreceived within the at least one helical shaped groove.
 6. The needle ofclaim 5, wherein the helical shaped groove passes completely through aside wall of the curvilinear tube.
 7. The needle of claim 5, wherein theinner tube includes a pair of protrusions disposed opposite one anotherand the curvilinear tube has two helical shaped grooves that aresymmetrically opposite one another.
 8. The needle of claim 5, whereinthe curvilinear tube mates with a first guide that only allows thecurvilinear tube to travel in the axial direction and prevents rotationof the curvilinear tube.
 9. The needle of claim 8, wherein thecurvilinear tube has a pin that is received within a linear slot thatcomprises the first guide.
 10. The needle of claim 9, wherein the linearslot is formed in the handle housing.
 11. The needle of claim 9, whereinthe linear slot is formed in the upper surface of the base.
 12. Theneedle of claim 5, wherein the upper surface of the base includes aconcave recessed section in which the curvilinear tube rests and travelsin an axial direction therein, the base including a first end wall at aproximal end wall of the base, wherein the curvilinear tube is disposedadjacent the first end wall.
 13. The needle of claim 12, wherein thesecond biasing mechanism comprises a second spring that is in contactwith a distal face of the first end wall and the first biasing mechanismcomprises a first spring that is contact with a proximal face of thefirst end wall.
 14. The needle of claim 13, wherein the base rides alonga pair of guide rails disposed within the handle housing, the guiderails passing through a pair of longitudinal bores formed through thebase.
 15. The needle of claim 1, further including a first actuator thatis configured to initiate the first stage and comprises a firststructure that selectively contacts the base so as to lock the base inan initial locked position and is movable to a second position in whichthe first structure is removed from the base and the base is free tomove and be driven axially as the first biasing mechanism releases itsstored energy.
 16. The needle of claim 15, further including a secondactuator that is configured to initiate the second stage and comprises asecond structure that selectively contacts the inner driven member so asto lock the inner driven member in an initial locked position and ismovable to a second position in which the second structure is removedfrom the inner driven member and the inner driven member is free to moveand be driven axially as the second biasing mechanism releases itsstored energy.
 17. A biopsy needle for collecting a tissue specimencomprising: a handle housing; an outer cannula that is at leastpartially received within the handle housing; an inner tube receivedwithin the outer cannula and configured to receive a stylet, wherein theouter cannula and inner tube extend distally beyond a distal end of thehandle housing; a snare coil attached between the inner tube and theouter cannula; a movable sled disposed within the handle housing,wherein the outer cannula is fixedly coupled to the movable sled, themovable sled being axially movable within the handle housing along oneor more guides; an inner driven structure that is coupled to the innertube and is configured to travel axially a defined distance within atrack formed in the movable sled while at the same being prevented fromrotating during axial travel, wherein one of the inner tube and theinner driven structure includes a pin and the other of the inner tubeand the inner driven structure includes a groove that receives the pinsuch that the axial driving of the inner driven structure impartsrotation to the inner tube relative to the outer cannula; a firstbiasing mechanism coupled to the movable sled for driving the movablesled in a distal axial direction when the first biasing mechanismreleases its stored energy; a second biasing mechanism coupled to theinner driven structure for driving the inner driven structure in thedistal axial direction along the movable sled when the second biasingmechanism releases its stored energy; wherein the first biasingmechanism defines a first stage of operation and the second biasingmechanism defines a second stage of operation, wherein in the firststage, the release of the stored energy of the first biasing mechanismcauses the movable sled and the inner tube and the outer cannula totravel axially in the distal direction for a defined distance and thesecond biasing mechanism is configured such that after the movable sledtravels a prescribed distance, the second biasing mechanism isautomatically tripped and releases its stored energy to cause the axialdriving of the inner driven structure resulting in rotation of the innertube relative to the outer cannula, thereby causing activation of thesnare coil.
 18. The needle of claim 17, further including a first manualreset mechanism that is accessible along an exterior of the handlehousing for manually driving the inner driven structure in a proximaldirection to cause the second biasing mechanism to store energy and toreleasably lock the inner driven structure in an initial position, and asecond manual reset mechanism that is accessible along an exterior ofthe handle housing for manually driving the movable sled in a proximaldirection to cause the first biasing mechanism to store energy and toreleasably lock the movable sled in an initial position.
 19. The needleof claim 17, wherein the movable sled includes a proximal end wall andthe first biasing mechanism is disposed between the proximal end walland a proximal surface defined within the handle housing.
 20. The needleof claim 20, further including a first release member that releasablyengages the movable sled and is movable between an engaged position inwhich the movable sled is engaged and prevented from moving axially anda released position in which the movable sled can move in an axialdirection and a second release member that releasably engages the innerdriven structure and is movable between an engaged position in which theinner driven structure is engaged and prevented from moving axially anda released position in which the inner driven structure can move in anaxial direction, wherein the movable sled includes a longitudinal slotto allow for passage of the second release member so as to permit thesecond release member to engage the inner driven structure.